Cardiogenic Shock, Heart Failure, Ischemic Heart Disease
Conditions
Keywords
Heart Failure, Cardiogenic shock, Ivabradine
Brief summary
Data regarding the safety and efficacy of ivabradine use in severely decompensated HFrEF requiring inotropic support is limited to case series.1 This study aimed to evaluate ivabradine safety and tolerability in admitted cardiogenic shock patients who started on dobutamine infusion for inotropic support.
Detailed description
Background and study rationale: Ivabradine is a Heart Rate (HR) lowering agent which acts by inhibiting the If current in the sinoatrial node. It is currently indicated in patients with chronic heart failure with reduced ejection fraction (HFrEF). Dobutamine is an inotropic drug used in cardiogenic shock patients and it is associated with an increase in HR and incidence of cardiac arrhythmias.2 However, studies have suggested that increased heart rate may be deleterious in decompensated HFrEF due to an inverted Bowditch-Treppe response. Data regarding the safety and efficacy of ivabradine use in severely decompensated HFrEF requiring inotropic support is limited to case series.1, 2 Aim of the work: * This study aims to evaluate ivabradine safety and tolerability in admitted cardiogenic shock patients who started on dobutamine infusion for inotropic support. * Design: Randomized open-label interventional clinical trial. Methods and patients: * Study Type: Interventional (Clinical Trial) * Estimated Enrollment: 200 participants * Allocation: Randomized * Perspective: Prospective Study * Intervention Model: Two Group Assignment * Masking: None (Open Label) * Primary purpose: Treatment * Official title: Ivabradine effects in cardiogenic shock requiring inotropic support (IVA-CS) * Start Date: 01 August 2022 * Estimated Primary Completion Date: 01 January 2023
Interventions
Patients will receive ivabradine 7.5 mg twice daily via oral route after dobutamine infusion by 30 minutes.
Dobutamine infusion by a dose that is titrated according to blood pressure Ranging from 5 to 20 ug/kg/minute
Sponsors
Study design
Eligibility
Inclusion criteria
* Decompensated heart failure with reduced ejection fraction (HFrEF) admitted for cardiogenic shock requiring inotropic support.
Exclusion criteria
* Decompensated heart failure with reduced ejection fraction (HFrEF) not requiring inotropic support. * Patients with no oral intake * Patients who refused to sign the consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of hospital stay | Up to 1 month | Total duration of hospital stay calculated in days |
| Heart rate reduction | Up to 7 days | Amount of reduction of heart rate calculated by subtracting the heart rate at the time of weaning from the initial heart rate |
| Time of weaning from dobutamine infusion | Up to 7 days | The time needed to completely wean dobutamine infusion calculated in hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ventricular arrhythmias (Ventricular Tachycardia and/or Fibrillation) | Up to 1 month | Any ventricular arrhythmias will be documented |
| Supraventricular arrhythmia | Up to 1 month | Any supraventricular arrhythmias will be documented |
Countries
Egypt